Topical Oxygen Therapy Used For Wound Care - An Update

On April 03, 2017, CMS revised Section C of Hyperbaric Oxygen (HBO) Therapy National Coverage Determination (NCD 20.29) to remove non-coverage language addressing topical oxygen therapy (TOT), allowing the DME MACs the discretion to determine coverage. This article will summarize the DME MACs’ review process.


On June 11, 2003, a product by Medical Solution Technologies Inc. was assigned HCPCS code A4575 (TOPICAL HYPERBARIC OXYGEN CHAMBER, DISPOSABLE). On January 01, 2004, the DME MACs revised the Oxygen and Oxygen Equipment LCD to indicate that A4575 would be denied as not medically necessary.

On January 01, 2011, HCPCS code E0446 (TOPICAL OXYGEN DELIVERY SYSTEM, NOT OTHERWISE SPECIFIED, INCLUDES ALL SUPPLIES AND ACCESSORIES) was added to the HCPCS Code Set, and a product by EO2 Concepts was assigned HCPCS code E0446. Concurrently, the DME MACs revised the Oxygen and Oxygen Equipment LCD to indicate that topical oxygen delivery systems (E0446) would be denied as not reasonable and necessary.

Review in Progress

Following the CMS decision in NCD 20.29 to defer to contractor discretion, the DME MACs elected to begin a review of the current clinical evidence regarding the use of TOT in wound care. In the fall of 2017, the DME MACs posted a Request for Information (RFI) regarding topical oxygen therapy used for wound care. The timeframe for submission of clinical literature extended from September 14, 2017 through October 30, 2017 (45 days). The DME MACs also received an inquiry from one manufacturer regarding coverage of their specific product for continuous diffusion of oxygen (CDO) for the treatment of chronic wounds, along with an accompanying bibliography.

The results from these 3 sources yielded one-hundred and fifty-two unique documents. Correspondence, Agency documents (CMS and FDA), etc. were removed from the document set, leaving one-hundred and thirty-one unique items included in the bibliography. These materials dated from 2017 back to 1967. For clinical relevance, an article publication age limit of 10 years was used (i.e., years 2007 – 2017), yielding sixty-four items for consideration. After non-clinical articles were removed, thirty-six articles remained for analysis. For record keeping purposes, these articles are listed in a separate document titled “Topical Oxygen Request for Information Bibliography.”

The thirty-six remaining clinical articles are being reviewed by the 4 DME MAC Medical Directors.

If interested parties have further information to submit that would modify the statement of non-coverage as it exists in the Oxygen and Oxygen Equipment LCD, it is advised that an LCD reconsideration request be submitted as outlined in the Medicare Program Integrity Manual (Internet-only manual 100-08), Chapter 13, §13.7.1. or on any of the DME MAC websites.

Additional information on the coverage, coding and documentation requirements for oxygen may be found in the Oxygen and Oxygen Equipment Local Coverage Determination and related Policy Article on the DME MAC web sites and the CMS Medicare Coverage Database.

Revision History

Date Update
10/18/2018 Published on PDAC website


Last Updated: 10/18/2018